The concept of disposable containers for the collection of bodily fluid specimens such as urine specimens is well known. U.S. Pat. Nos. 5,368,583 and, 4,990,145 and 3,797,734 all show a disposable bag for collecting bodily fluids. Specifically, the '734 patent shows a bag having a tubular funnel sealingly engaging a plastic bag. The bag is sealably attached over the outer surface of a tubular member. The lower end of the tubular member includes valve means comprised of a flat plastic tube capable of being flattened which allows entry of the fluid downward through the tubular member and into the bag but which prevents fluid from migrating upward and re-entering the tubular member. The '145 patent provides an improvement to the embodiment disclosed in the '734 patent by means of a protective outer sleeve or shroud for protecting the user's skin against fluid contact. As noted in the '145 patent, products made in accordance with both patents have been sold in substantial numbers. Finally, the test kit disclosed in the '583 patent includes the improvements disclosed in the '145 patent and further includes an improved closure means at the upper end of the tubular member which facilitates the deposit of a test strip in the disposable container.
The primary problem with the disposable containers disclosed in the '734, '145 and '583 patents is that there is no safe and , easy means for withdrawing a fluid sample from a filled collection bag for further testing and/or processing. Specifically, while a test strip may be deposited downward into the container disclosed in the '583 patent, there is no easy means for the technician to withdraw a small fluid sample or a test sample from the bag without potentially exposing the technician to fluid contact. Thus, there is still a further need for an improved disposable specimen container from which a test sample may be withdrawn.
It is also imperative that technicians be able to withdraw test samples without danger of spillage or exposure to the fluid test sample. Hepatitis B virus, HIV (Human Immunodeficiency Virus) and other diseases may be transmitted as a result of contact with bodily fluids. Further, the Occupational Safe and Health Administration (OSHA) has issued regulations that medical practices must comply with (see 29 CFR .sctn. 1910.1030 et seq.). Thus, there is a need for a disposable specimen container that is easy to use and protects both the patient and medical technician against coming in contact with the bodily fluids and further that enables the medical technician to withdraw a test sample without danger of contact or spillage.